Pre Treatment.jpg: Benign prostatic hyperplasia (BPH) is an enlargement of the prostate gland, affecting 12 million men in the U.S., with nearly 800,000 newly diagnosed each year. An enlarged prostate squeezes down on the urethra causing lower urinary tract symptoms.

Response: Male lower urinary tract symptoms due to benign prostatic hyperplasia, or LUTS due to BPH, have most commonly been treated with a combination of medication, such as alpha-blockers and 5-alpha reductase inhibitors, and surgery, such as transurethral resection of prostate (TURP) and Greenlight photovaporization of prostate (PVP). These treatments, however, have potentially serious adverse and sexual side effects. Minimally invasive surgical therapies (MIST) for LUTS due to BPH have tried to thread the needle between medications and invasive surgery, giving effective relief of symptoms with minimal anesthetic need while preserving sexual function. Previously developed MISTs have been unable to provide durable relief of symptoms, causing patients to undergo multiple treatments in a short period of time, and have been limited by prostate size and conformation, e.g. the inability to treat a middle lobe or median bar. LUTS due to BPH is also very strongly and likely causally linked with obesity, and obesity seems to have an effect on the efficacy of treatment as well, as obesity affects response to medication and tends to dampen the treatment effect of TURP.

Convective Radiofrequency Water Vapor Energy ablation of the prostate, named Rezūm®, is a new MIST that uses radiofrequency to generate energy in the form of water vapor. The water vapor acts as a convective energy source and, once injected into the treatment area, distributes itself evenly within the treated tissue, causing uniform necrosis througout the treated area. This mechanism using convection is in contrast to previous technologies using conductive heat energy, which created a heat gradient with tissue closest to the heat source receiving the largest amount of energy and tissue farthest from the heat source receiving almost no energy. Thus conductive energy has a different effect on different parts of the treated area. With Rezūm, MRI studies have shown that the water vapor creates a uniform treatment effect while staying within collagen barriers, obeying natural tissue planes and affecting only the intended treatment areas.

The purpose of this study was to determine the efficacy of Rezūm in treatment of LUTS due to BPH, examine the treatment’s effect on sexual function, and to determine whether obesity affected treatment efficacy.

Blayne Welk, MD, FRCSCAssistant Professor of Surgery
Western University

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: Concerns have been raised by regulatory agencies and patients about possible serious psychiatric side effects associated with the use of 5 alpha reductase inhibitors. These medications can be used for both enlarged prostates and alopecia.

We used administrative data to assess for potential psychiatric side effects associated with finasteride and dutasteride usage in older men with benign prostatic enlargement.

In our study we found that there was no increased risk of suicide associated with the use of these medications. However, there was a small increase in both self-harm and new onset depression associated with the use of 5 alpha reductase inhibitors.Continue reading →

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: Enlarged prostate, also known as benign prostatic hyperplasia (BPH), is one of the most common prostate problems occurring in men older than 50. According to the National Institutes of Health, as many as 14 million men in the U.S. had symptoms suggestive of BPH, which can affect 50 percent of men between 51 and 60 years of age and up to 90 percent of men older than 80. A few years ago, Dr. João Martins Pisco developed the minimally invasive treatment, known as prostate artery embolization, to treat BPH. The study that Dr. Pisco presented at the Society of Interventional Radiology on March 8 is the first of its kind – a study with 1,000 patients with long-term efficacy data.

Between March 2007 and March 2016, Dr. Pisco and his team performed PAE on 1,000 men who averaged 67 years of age. All patients were evaluated in the short term (one, three, and six months), 807 patients were seen through the medium term (every six months between six months and three years), and 406 patients were evaluated long term (every year after three years).

During each evaluation, the men’s symptoms were measured by the International Prostate Symptom Score (IPSS), which tests for the blockage of urine flow, and the International Index of Erectile Function (IIEF), which assesses erectile dysfunction. Researchers also measured the size of the prostate and the amount of urine left in the bladder after urination. They also evaluated the peak urinary flow rate and the prostate-specific antigen (PSA) level, a test used to screen for prostate cancer.

MedicalResearch.com: What are the main findings?

Response: The data from these measures revealed at the short-term mark that the treatment had an 89 percent cumulative success rate—measuring the success across all variables through the given testing period. The 807 men evaluated at the medium-term mark had an 82 percent success rate. And of the 406 patients measured at the long-term mark, 78 percent were considered cumulative successes.

In an additional analysis, researchers found that among 112 patients who also suffered acute urinary retention (AUR) before undergoing PAE, 106 or 94.6 percent had their catheter removed between two days and three months after treatment. At medium-term and long-term follow up, 95 of the 112 (84.8 percent) and 89 of the 112 (78.5 percent) did not experience any recurrence of their AUR.

The team also performed PAE in 210 patients who had limited treatment options due to extreme enlargement of the prostate (larger than 100 cm³). Of these men, 84 percent experienced cumulative success at short-term evaluation and 76.2 percent at medium- and long-term. The normal size of a prostate is 15 cm3 to 30 cm3.

MedicalResearch.com: What should readers take away from your report?

Response: Prostate artery embolization gives men with BPH a treatment option that is less invasive than other therapies and allows them to return to their normal lives sooner. Time and time again, Dr. Pisco has seen patients who are relieved to find out about PAE because they are not able to tolerate medications for BPH due to their side effects. These men also don’t want traditional surgery because it involves greater risks, has possible sexual side effects, and has a recovery time that is relatively long compared to PAE, which is generally performed under local anesthesia and on an outpatient basis.

Prostate artery embolization should also be presented to patients who are exploring options to resolve their BPH.

That said, PAE may not be appropriate for all patients, such as those with advanced arterial atherosclerosis that may be due to smoking or diabetes. Patients should speak with an interventional radiologist or other members of their care team to discuss treatment options.

MedicalResearch.com: What recommendations do you have for future research as a result of this study?

Response: As a next step, Dr. Pisco and his team are now conducting a study comparing the effectiveness of PAE to a sham – or placebo—treatment to address any possible placebo effect that may have occurred during Pisco’s research with these 1,000 patients.

MedicalResearch.com: Is there anything else you would like to add?

Response: Prostate artery embolization is a safe and effective treatment and these data demonstrate the efficacy of the therapy in the long term. It’s important that patients know about this therapy as they explore how to resolve their BPH.

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